Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06937086 | Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study | PHASE3 | RECRUITING | 350 | — | — | Jun 26, 2025 | Apr 1, 2028 | Jun 3, 2026 | 190 | United States, Austria +21 |
| NCT05784246 | A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis | PHASE3 | COMPLETED | 63 | — | — | Nov 22, 2023 | May 1, 2026 | Jun 3, 2026 | 34 | United States, Belgium +9 |
| NCT05767021 | A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis | PHASE3 | ACTIVE NOT_RECRUITING | 172 | — | — | May 17, 2023 | Apr 1, 2026 | Oct 28, 2025 | 120 | United States, Belgium +8 |
| NCT04844606 | A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) | PHASE3 | RECRUITING | 150 | — | — | May 26, 2021 | Dec 1, 2030 | Jun 3, 2026 | 67 | United States, Austria +14 |
| NCT03524092 | A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis | PHASE3 | COMPLETED | 1,328 | — | — | Oct 19, 2018 | Feb 17, 2025 | May 13, 2026 | 385 | United States, Argentina +32 |
| NCT03519945 | A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | PHASE3 | ACTIVE NOT_RECRUITING | 1,058 | — | — | Jul 18, 2018 | Dec 1, 2027 | Apr 20, 2026 | 352 | United States, Argentina +34 |
| NCT03518086 | An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | PHASE3 | COMPLETED | 1,281 | — | — | Jun 18, 2018 | May 15, 2024 | May 31, 2025 | 502 | United States, Argentina +33 |
| NCT04004611 | A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) | PHASE2 | COMPLETED | 26 | — | — | May 18, 2020 | Mar 15, 2023 | Mar 26, 2024 | 37 | United States, Canada +3 |
| NCT02589665 | A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis | PHASE2 | COMPLETED | 249 | — | — | Dec 9, 2015 | May 7, 2019 | Jun 17, 2020 | 76 | United States, Australia +14 |
Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.
The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for all other randomized participants.
Clinical Remission based on the MMS
Clinical Remission based on the PCDAI
Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received.
Clinical remission based on the modified Mayo Score (MMS).
Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The confidence interval of 99.88% was chosen to match the significance level.
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding Physician's Global Assessment (PGA). * Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); * Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
| Arm | Type | Description |
|---|---|---|
| Mirikizumab + Tirzepatide | EXPERIMENTAL | Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC. |
| Mirikizumab + Placebo | EXPERIMENTAL | Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC. |
| Mirikizumab Weight-Based Group 1 | EXPERIMENTAL | Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). |
| Mirikizumab Weight-Based Group 2 | EXPERIMENTAL | Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. |
| Mirikizumab Weight-Based Group 3 | EXPERIMENTAL | Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. |
| 300 mg Mirikizumab | EXPERIMENTAL | Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV). |
| Mirikizumab Dose 1 for UC | EXPERIMENTAL | Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight. |
| Mirikizumab Dose 2 for UC | EXPERIMENTAL | Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
| Mirikizumab Dose 3 for UC | EXPERIMENTAL | Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
| Mirikizumab Dose 4 for CD | EXPERIMENTAL | Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
| Mirikizumab Dose 5 for CD | EXPERIMENTAL | Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
| Mirikizumab Dose 6 for CD | EXPERIMENTAL | Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
| Mirikizumab Dose 7 for UC or CD | EXPERIMENTAL | Intravenous (IV) rescue dosing, if response is lost. |
| Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC) | PLACEBO_COMPARATOR | Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed. |
| Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC | EXPERIMENTAL | Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. |
| Maintenance Period: PBO IR - PBO SC | EXPERIMENTAL | Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. |
| Maintenance Period: Miri IR - PBO SC - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed. |
| Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. |
| Maintenance Period: PBO IR - PBO SC - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. |
| Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV | EXPERIMENTAL | Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses. |
| LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses. |
| Extended Induction: Induction Nonresponders - 300mg Miri IV | EXPERIMENTAL | Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12. |
| Extended Induction: Induction Nonresponders - 300mg Miri IV - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12. |
| Open Label Maintenance: Delayed Responders - 200 mg Miri SC | EXPERIMENTAL | Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants). |
| Open Label Maintenance: Delayed Responders - 200 mg Miri SC - ME2 Cohort | EXPERIMENTAL | Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants). |
| Mirikizumab | EXPERIMENTAL | Mirikizumab administered subcutaneously (SC). |
| Placebo Intravenous (IV) Every 4 Weeks (Q4W) | PLACEBO_COMPARATOR | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| 300 Milligram (mg) Mirikizumab IV Q4W | EXPERIMENTAL | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| Placebo IV Q4W Maximum Extended Enrollment (ME2) | PLACEBO_COMPARATOR | Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| 300 mg Mirikizumab IV Q4W ME2 | EXPERIMENTAL | 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. |
| Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV) | EXPERIMENTAL | Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks. |
| Open Label Induction Period: 10 mg/kg Miri IV | EXPERIMENTAL | Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. |
| Open Label Induction Period: 300 mg Miri IV | EXPERIMENTAL | Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks. |
| Open Label Maintenance Period: 50 mg Miri subcutaneous (SC) | EXPERIMENTAL | Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: 100 mg Miri SC | EXPERIMENTAL | Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: 200 mg Miri SC | EXPERIMENTAL | Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC | EXPERIMENTAL | Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC | EXPERIMENTAL | Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed. |
| Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC | EXPERIMENTAL | Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed. |
| 50 mg Mirikizumab IV Q4W (Induction) | EXPERIMENTAL | 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. |
| 200 mg Mirikizumab IV Q4W (induction) | EXPERIMENTAL | 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. |
| 600 mg Mirikizumab IV Q4W (Induction) | EXPERIMENTAL | 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. |
| Placebo IV Q4W (Induction) | PLACEBO_COMPARATOR | Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period. |
| 200 mg Mirikizumab SC Q4W (Maintenance) | EXPERIMENTAL | Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period. |
| 200 mg Mirikizumab SC Q12W (Maintenance) | EXPERIMENTAL | Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period. |
| Placebo SC Q4W (Maintenance) | PLACEBO_COMPARATOR | Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period. |
| 600mg Mirikizumab IV Q4W Extension Open-Label | EXPERIMENTAL | Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label. |
| 1000mg Mirikizumab IV Q4W Extension Open-Label | EXPERIMENTAL | Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label. |
| 200mg Mirikizumab SC Q4W Extension Open-Label | EXPERIMENTAL | Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label |
| Name | Type | Description |
|---|---|---|
| Mirikizumab | DRUG | Administered IV |
| Tirzepatide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Mirikizumab IV | DRUG | Administered IV |
| Mirikizumab SC | DRUG | Administered SC |
| Placebo SC | DRUG | Administered SC |
Inclusion Criteria: * Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and en...